Rockwell Medical: FDA Accepts Triferic As Proprietary Trade Name For SFP

(RTTNews) - Rockwell Medical (RMTI) announced the U.S. Food & Drug Administration or FDA accepted the proposed proprietary trade name Triferic for the company's investigational iron-delivery drug, previously known as Soluble Ferric Pyrophosphate or SFP, which is intended for treating iron deficiency in chronic kidney disease patients receiving hemodialysis.

The company stated that a request for proprietary name review for Triferic will be filed with the New Drug Application or NDA submission.

Rockwell recently announced successful top-line results from its long-term Phase 3 CRUISE-1 and CRUISE-2 efficacy studies of Triferic. Triferic is the Company's late-stage investigational iron-delivery drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis.

In both studies, Triferic met the primary endpoint, demonstrating a statistically significant mean change in hemoglobin from baseline to End-of-Treatment. Additionally, Triferic met key secondary endpoints, including maintenance of hemoglobin, maintenance of reticulocyte hemoglobin, and increase in serum iron pre-to-post treatment without an increase in ferritin.